Author, as appears in the article.: Arija V; Fargas F; March G; Abajo S; Basora J; Canals J; Ribot B; Aparicio E; Serrat N; Hernández-Martínez C; Aranda N

Department: Psicologia Medicina i Cirurgia Ciències Mèdiques Bàsiques

URV's Author/s: Aparicio Llopis, Estefania / Aranda Pons, Núria / Arija Val, Maria Victoria / Basora Gallisa, Josep / Canals Sans, Josefa / Hernandez Martinez, Carmen / RIBOT SERRA, BLANCA

Abstract: Background: Currently, there is no consensus regarding iron supplementation dose that is most beneficial for maternal and offspring health during gestation. Recommended iron supplementation dose does not preempt anemia in around 20% of the pregnancies, nor the risk of hemoconcentration in 15%. This deficit, or excess, of iron prejudices the mother-child wellbeing. Therefore the aims of the study are to determine the highest level of effectiveness of iron supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum for mother-child health.Methods/Design: Design: Randomized Clinical Trial (RCT) triple-blinded. Setting: 10 Primary Care Centers from Catalunya (Spain). Study subjects: 878 non-anemic pregnant women at early gestation stage, and their subsequent newborns. Methods: The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of gestation. Stratum #1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 80 mg/d. Stratum #2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 20 mg/d. Measurements: In the mother: socio-economic data, clinical history, food item frequency, lifestyle and emotional state, and adherence to iron supplement prescription. Biochemical measurements include: Hb, serum ferritin, C reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children: ultrasound fetal biometry, anthropometric measurements, and temperament development.Statistical analyses, using the SPSS program for Windows, will include bivariate and multivariate analyses adjusted for variables associated with the relationship under study.Discussion: Should conclusive outcomes be reached, the study would indicate the optimal iron supplementation dose required to promote maternal and infant health. These results would contribute towards developing guidelines for good clinical practice.Trial registration: This clinical trial is registered at http://www.clinicaltrialsregister.eu as EudraCT number 2012-005480-28. © 2014 Arija et al.; licensee BioMed Central Ltd.

Thematic Areas: Surgery Serviço social Saúde coletiva Odontología Obstetrics and gynecology Obstetrics & gynecology Nutrição Medicina iii Medicina ii Medicina i Materiais Matemática / probabilidade e estatística Interdisciplinar Ensino Enfermagem Educação física Ciências biológicas iii Ciências biológicas ii Ciências biológicas i Biotecnología Administração pública e de empresas, ciências contábeis e turismo

licence for use: https://creativecommons.org/licenses/by/3.0/es/

ISSN: 14712393

Author's mail: estefania.aparicio@urv.cat josep.basora@urv.cat nuria.aranda@urv.cat victoria.arija@urv.cat josefa.canals@urv.cat josep.basora@urv.cat carmen.hernandez@urv.cat

Author identifier: 0000-0003-0542-0015 0000-0001-9708-747X 0000-0002-1758-0975 0000-0002-6209-9558 0000-0001-6328-8679

Record's date: 2023-02-19

Papper version: info:eu-repo/semantics/publishedVersion

Link to the original source: https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/1471-2393-14-33

Licence document URL: http://repositori.urv.cat/ca/proteccio-de-dades/

Papper original source: Bmc Pregnancy And Childbirth. 14 (1): 33-

APA: Arija V; Fargas F; March G; Abajo S; Basora J; Canals J; Ribot B; Aparicio E; Serrat N; Hernández-Martínez C; Aranda N (2014). Adapting iron dose supplementation in pregnancy for greater effectiveness on mother and child health: Protocol of the ECLIPSES randomized clinical trial. Bmc Pregnancy And Childbirth, 14(1), 33-. DOI: 10.1186/1471-2393-14-33

Article's DOI: 10.1186/1471-2393-14-33

Entity: Universitat Rovira i Virgili

Journal publication year: 2014

Publication Type: Journal Publications